An Active Surveillance Program for Cases of Medullary Thyroid Carcinoma (MTC)
This study is enrolling participants by invitation only.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01511393
First received: November 30, 2011
Last updated: May 1, 2013
Last verified: December 2012
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Purpose
This study is conducted in the United States of America (USA). The aim of this study is to monitor the number of annual new cases of medullary thyroid carcinoma (MTC) and to establish a registry for these new cases in order identify any possible increase related to the introduction of liraglutide and other GLP-1 analogs into the U.S. market.
| Condition | Intervention |
|---|---|
|
Diabetes Diabetes Mellitus, Type 2 Medullary Thyroid Carcinoma |
Other: No treatment given |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Medullary Thyroid Carcinoma Surveillance Study: A Case-Series Registry |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Annual incidence of MTC in the US to identify any possible increase related to the introduction of liraglutide and other GLP-1 analogs into the US market [ Time Frame: December 2011 to December 2025 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Family history of cancer (including history of MEN2A or MEN 2B, history of FMTC, history of RET proto-oncogene mutations) [ Time Frame: December 2011 to December 2025 ] [ Designated as safety issue: No ]
- Dose and duration of use of all previous diabetes medication exposures (including liraglutide, other GLP-1 agonists, DPP4 inhibitors, and insulin) [ Time Frame: December 2011 to December 2025 ] [ Designated as safety issue: No ]
- Lifestyle factors such as smoking and alcohol use [ Time Frame: December 2011 to December 2025 ] [ Designated as safety issue: No ]
- Environmental exposures (occupational history, radioiodine exposure, nuclear fallout) [ Time Frame: December 2011 to December 2025 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 6750 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2025 |
| Estimated Primary Completion Date: | December 2025 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Questionnaire |
Other: No treatment given
Completion of a questionnaire
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
People with medullary thyroid carcinoma invited by either written invitation from the participating cancer registry or the diagnosing physician to participate in the study.
Criteria
Inclusion Criteria:
- A record of medullary thyroid carcinoma (MTC) identified from state/regional population-based cancer registries
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT01511393 History of Changes |
| Other Study ID Numbers: | NN2211-3965, U1111-1125-4362 |
| Study First Received: | November 30, 2011 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Thyroid Neoplasms Diabetes Mellitus Diabetes Mellitus, Type 2 Thyroid Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Head and Neck Neoplasms Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013